This is an exciting opportunity for a part time home based In-House Clinician to join our dynamic team.
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 43,000 people in more than 100 countries, delivers> innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains.
Intertek’s business assurance team provides a comprehensive range of auditing and certification services ensuring that management systems are optimized to facilitate successful growth. Products and services are only as good as the management systems that support them. Intertek provide the tools needed to evaluate and continually improve business processes. With a high level of technical expertise and a customer-focused approach, they look beyond the standard to provides audit that add strategic value to a business.
About the role
The role is a part time, home based role and will involve supporting SEMKO AB Notified Body and the Intertek Medical Notified Body AB (IMNB), in a range of clinical maters.
The Notified Bodies (wholly owned subsidiaries of Intertek) provides Conformity Assessments for a range of medical device families, including accredited third-party management systems auditing and certification.
The role has accountability to support the operation of the business by providing clinical oversight of clinical conformity assessments of the device Manufacturer’s clinical evidence to ensure compliance with the conformity assessment requirements set out in EU Council Directive 93/42/EEC, as well as the new Medical Device Regulation 2017/745 (MDR) in the near future. This will be performed in a timely and accurate manner, in accordance with documented procedures, forms and registers forming part of the Notified Body’s Quality Management System.
The role holder is also required to:
- Deliver training and advice to notified body staff;
- Provide clear, consistent and clinically sound reports and advice, appropriate for the specific recipient audience
- Participate in meetings for training and liaison with external experts as well as addressing clinical concerns with manufacturers
- Complete clinical reviews in a timely manner, within current regulatory requirements and for a wide range of medical device families
- Additional information
- The role holder will be required to work part time to allow continuation of clinical practice.
Required skills and experience
- A medical (MD) qualification and specialist training in a relevant medical specialty;
- A form of ongoing clinical involvement to ensure device knowledge is current;
- Meet and maintain appropriate registration requirements with a license to practice;
- Good IT literacy skills;
- bility to work to set time frames once scheduled for a project
- The ideal candidate will also have:
- Current knowledge and experience of using a broad range of medical devices, covering a wide range of NBOG medical device product families;
- An understanding of EU Regulatory requirements as applicable to the medical devices that SEMKO AB is accredited for and IMNB will be under the MDR;
- Experience in clinical investigation studies in the EU involving medical devices;
- Experience of giving internal advice on clinical matters related to novel features of devices, medical device vigilance, and medical device risk assessments.
- Results driven to focus contribution on activities which meet company goals and deliver the greatest value
- Ability to critique and improve activities through continuous improvement and innovation The ability to demonstrate respect, equity and empathy for a diverse community
- Motivated, self-starter
- Encourage teamwork (promote operational synergies and alignment) to support each other, our customers and grow together
- Highly energised mindset with willingness and desire to learn and adapt individually
- Drive performance by ensuring performance expectations are met
- Fosters integrity and honesty
- Ensure compliance to company, industry and regulatory standards
- Ability to demonstrate exceptional customer service
- Highly organised with strong attention to detail
- Confident communicator (written/ oral) and able to build rapport, quickly and effectively
- Demonstrates flexibility and resilience to meet the demands of the role
- Able to act on own initiative
- Excellent time management
- Promotes company values to others and supports values in daily activities and decisions
HOW TO APPLY
Please provide a CV, Covering Letter (outlining your suitability for the role) and Salary Expectations by clicking the apply button including the reference Intertek850. All candidates will be required to confirm eligibility to work in the UK before starting employment.
Intertek has been a pioneer for 130 years.
Our rich history reaches back over 130 years to some of the world’s leading pioneers in the Quality Assurance industry. Our story starts at the inception of the modern testing industry and evolved from the combined growth of a number of innovative companies.
We are a leading Total Quality Assurance provider to industries worldwide.
Today Intertek a global force and continues to innovate to offer superior customer service. Our network of more than 1,000 laboratories and offices and over 43,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains.
True to the innovative spirit of our founders, we are continuing to re-define the industry with our Total Quality Assurance value proposition – going beyond physical quality control through our Testing, Inspection and Certification services to offering Total Peace of Mind, as we additionally provide Assurance services, ensuring our customers’ operating procedures and systems are functioning properly.
Behind it lies our Customer Promise – Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.
It is our people that make the difference – be one of us.
Intertek is a family that is committed to working together to bring quality and safety to life in an environment which respects diverse perspectives, experiences and traditions as essential, and values each employee’s contribution toward achieving their business objectives.
By joining Intertek’s global team you will share our vision of becoming the world’s most trusted partner for Quality Assurance. In addition you will work with some of the best, brightest, and most inspiring people in the Assurance, Testing, Inspection, and Certification industry who go above and beyond to deliver Total Quality Assurance to industries worldwide whilst exceeding customer expectations, globally 24/7.
As a matter of courtesy, we will try to respond to all applications. However, due to the volume of applications received, we may not be able to respond to individual candidates. If you have not been contacted within four weeks unfortunately, your application has been unsuccessful. Please do not let this deter you from applying for vacancies in the future should you meet the minimum requirements of the role.
Intertek operates a preferred supplier arrangement and we do not accept unsolicited approaches from agencies
Closing date: 13 November 2018.